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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name abutment, implant, dental, endosseous
510(k) Number K083544
Device Name KAT IMPLANT SYSTEM
Applicant
KAT IMPLANTS, LLC
15 RYE STREET
SUITE 115
PORTSMOUTH,  NH  03801
Applicant Contact VITALI BONDAR
Correspondent
KAT IMPLANTS, LLC
15 RYE STREET
SUITE 115
PORTSMOUTH,  NH  03801
Correspondent Contact VITALI BONDAR
Regulation Number872.3630
Classification Product Code
NHA  
Date Received11/28/2008
Decision Date 02/02/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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